Carvedilol Pregnancy and Breastfeeding Warnings

Carvedilol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Risk Summary: Brief statement (only if US FDA pregnancy category: Not assigned.)
Comments:
-Beta blockers reduce placental perfusion which may result in intrauterine fetal death and immature and premature deliveries.
-Adverse reactions (e.g., hypoglycemia, hypotension, bradycardia, respiratory depression, hypothermia) may occur in the fetus and neonate.
-There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.
-If this drug is used during pregnancy, therapy should be stopped 2 to 3 days before the expected birth; if this is not possible then the newborn should be monitored for the first 2 to 3 days of life.

There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Carvedilol Breastfeeding Warnings

This drug appears to present a low risk to the breastfed infant; however, because there is no published experience during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comment:
-The effects in the nursing infant are unknown; however, the possibility of the consequences of alpha and beta blockade should be considered.

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